AzTrials
AzTrials

StrokeNCT07629687

Non-invasive Auricular Vagus Nerve Stimulation (taVNS) on Postural Control and Autonomic Responses in Stroke

A study testing Vagus Nerve Stimulation combined with Balance Training Group and Balance Training Group in people with Stroke, run by Riphah International University at 1 site in Pakistan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This randomized controlled trial is conducted to determine the effects of transcutaneous auricular Vagus nerve stimulation (taVNS) on postural control in stroke patients (e.g., improvements in balance, mobility, and functional stability) and to evaluate the effects of taVNS on autonomic nervous system responses in… Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Stroke
What is being tested?
Vagus Nerve Stimulation combined with Balance Training Group and Balance Training Group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 sitePakistan
Study dates
20 May 2026to 20 Nov 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age between 18 to 70years who are diagnosed with ischemic brain injury, intracerebral hemorrhage shown by magnetic resonance imaging, or computed tomography.
  • First occurrence of stroke characterized by a unilateral lesion, with an onset time (acute/ subacute) < 6 months
  • With balance impairment (BBS Score = 21-44);
  • no or mild spasticity on the lower-limb assessed by Modified Ashworth Scale (MAS ≤ 2);
  • sufficient cognition to follow the instructions provided by the therapists and the computer.

Who cannot join

  • Individuals exhibiting unstable vital signs, consciousness disorders, or an inability to cooperate with examination and treatment procedures
  • Those with a heart rate below 60 beats per minute, or with implantable devices such as pacemakers or cochlear implants.
  • Other medical or psychological conditions affecting participation

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Arshad Nawaz Malik, PhD Rehab contact

03334503754

arshad.nawaz@riphah.edu.pk

Pakistan1 site, 1 recruiting
  • Railway General Hospital, Rawalpindi

    Islamabad, Punjab Province, 44000

    Arshad Nawaz Malik, PhD Rehab, 03334503754, arshad.nawaz@riphah.edu.pk

    Hajra Arshad, MS-NMPT*

    Recruiting

Other trials in Pakistan

About this study

Official title: Effects of Non-invasive Auricular Vagus Nerve Stimulation (taVNS) on Postural Control and Autonomic Responses in Stroke Patients

This randomized controlled trial is conducted to determine the effects of transcutaneous auricular Vagus nerve stimulation (taVNS) on postural control in stroke patients (e.g., improvements in balance, mobility, and functional stability) and to evaluate the effects of taVNS on autonomic nervous system responses in stroke patients (e.g., changes in heart rate variability, blood pressure variability, skin conductance, and temperature).

Read the detailed description

Stroke remains one of the leading causes of long-term disability worldwide, impacting millions of individuals each year. Beyond motor and cognitive deficits, stroke survivors often experience significant impairments in postural control and autonomic nervous system (ANS) regulation, both of which are essential for functional independence and overall quality of life. Impaired balance increases the risk of falls, while autonomic dysfunction-manifesting as irregular heart rate variability (HRV), blood pressure variability (BPV), and abnormal skin conductance and temperature-can lead to complications affecting cardiovascular stability and daily functioning.

Traditional rehabilitation approaches primarily focus on physical therapy to improve movement and strength; however, interventions that target neuromodulation and autonomic regulation are still underutilized in post-stroke care. This gap opens the door for novel, non-invasive techniques that can enhance neural recovery and improve both motor control and autonomic function.

Transcutaneous auricular vagus nerve stimulation (taVNS) is a non-invasive method that stimulates the auricular branch of the vagus nerve through external electrodes placed on parts of the ear, typically the tragus or cymba conchae. The vagus nerve is a critical component of the parasympathetic nervous system and plays a key role in maintaining autonomic balance, inflammatory regulation, and neuroplasticity. By stimulating the vagus nerve, taVNS is believed to influence brain regions associated with motor control, cardiovascular regulation, and arousal-including the nucleus tractus solitarius (NTS), locus coeruleus, thalamus, and insula.

Recent studies have shown that taVNS may enhance post-stroke recovery by promoting cortical reorganization, reducing neuroinflammation, and improving neural connectivity. It has also been found to modulate HRV and BPV, reflecting improvements in autonomic nervous system activity, and may contribute to better cardiovascular health and stress resilience. This randomized controlled trial aims to explore the therapeutic potential of taVNS in improving postural control and autonomic responses in patients recovering from stroke. Participants will receive taVNS using clinically standardized stimulation parameters (e.g., 25 Hz frequency, 250 μs pulse width, up to 6 mA intensity) administered for 30 minutes daily over 4 weeks. Postural outcomes will be evaluated using validated tools such as the Berg Balance Scale (BBS), Postural Assessment Scale for Stroke Patients (PASS), and Fugl-Meyer Assessment for Lower Extremities (FMA-LE). Autonomic responses will be assessed through heart rate variability, blood pressure variability, skin conductance, and skin temperature monitoring.

This study is significant because it addresses an important gap in stroke rehabilitation: the lack of non-invasive, targeted interventions that simultaneously improve both balance and autonomic function. By evaluating the dual impact of taVNS on these domains, this research has the potential to inform future stroke rehabilitation protocols, contributing to more holistic, patient-centered care. If effective, taVNS may offer a low-cost, portable, and easily integrated adjunct to conventional therapy, especially in low-resource settings or for patients with limited access to specialized care. In summary, this study investigates whether taVNS can serve as an effective tool to support postural stability and autonomic regulation in stroke survivors ultimately aiming to enhance recovery outcomes, reduce fall risk, and improve quality of life.

Conditions
Stroke
Being tested
Vagus Nerve Stimulation combined with Balance Training Group, Balance Training Group
Keywords
Stroke rehabilitation, Transcutaneous auricular vagus nerve stimulation, Postural control, Balance, Autonomic functions
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vagus Nerve Stimulation combined with Balance Training GroupOther

    Participants in the experimental group will receive transcutaneous auricular vagus nerve stimulation (taVNS) administered according to standardized clinical protocols. No intervention is provided at baseline, aside from initial assessments. During Weeks 1 and 2, taVNS will be applied daily or as per a specified schedule. The stimulation parameters include: application at the auricular site (such as the tragus), with a frequency of 25 Hz, pulse width of 250 µs, and intensity adjusted to individual tolerance, not exceeding 6 mA. Each session will last for 30 minutes. The same taVNS protocol continues through Weeks 3 and 4. This group will not perform physical balance exercises during the taVNS phase, focusing solely on neuromodulation through vagus nerve stimulation.

  • Balance Training GroupOther

    Participants in the control group will also undergo baseline assessments without intervention. During Weeks 1 and 2, they will participate in daily or scheduled 30-minute balance training sessions, consisting of 14 basic exercises such as sit-to-stand, tandem stance, and single-leg stance. These exercises are designed to improve static and dynamic balance, and are tailored to the individual's ability and safety level. In Weeks 3 and 4, the balance training progresses in difficulty. This includes increasing repetitions or duration, adding dual-task challenges (like cognitive tasks while balancing), and incorporating tools like foam pads or wobble boards to increase instability and challenge postural control. Each session remains 30 minutes in length and is supervised for safety and consistency

Study groups in NCT07629687
Study groupRoleWhat they receive
Vagus Nerve Stimulation combined with Balance TrainingExperimentalParticipants in the experimental group will receive transcutaneous auricular vagus nerve stimulation (taVNS) administered according to standardized clinical protocols. No intervention is provided at baseline, aside from initial assessments. During Weeks 1 and 2, taVNS will be applied daily or as per a specified schedule. The stimulation parameters include: application at the auricular site (such as the tragus), with a frequency of 25 Hz, pulse width of 250 µs, and intensity adjusted to individual tolerance, not exceeding 6 mA. Each session will last for 30 minutes. The same taVNS protocol continues through Weeks 3 and 4. This group will not perform physical balance exercises during the taVNS phase, focusing solely on neuromodulation through vagus nerve stimulation.
Receives: Other: Vagus Nerve Stimulation combined with Balance Training Group
Balance TrainingActive comparatorParticipants in the control group will also undergo baseline assessments without intervention. During Weeks 1 and 2, they will participate in daily or scheduled 30-minute balance training sessions, consisting of 14 basic exercises such as sit-to-stand, tandem stance, and single-leg stance. These exercises are designed to improve static and dynamic balance, and are tailored to the individual's ability and safety level. In Weeks 3 and 4, the balance training progresses in difficulty. This includes increasing repetitions or duration, adding dual-task challenges (like cognitive tasks while balancing), and incorporating tools like foam pads or wobble boards to increase instability and challenge postural control. Each session remains 30 minutes in length and is supervised for safety and consistency.
Receives: Other: Balance Training Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Berg Balance Scale (BBS)

    A clinical tool used to assess static and dynamic balance through 14 functional tasks. Tasks include sitting, standing, reaching, turning, and single-leg stance. It evaluates a person's ability to maintain balance during common daily activities and helps determine the risk of falls, especially in stroke patients and older adults.

    Scoring: Each item is scored from 0 to 4 (maximum score: 56)

    • Low fall risk: 41-56
    • Moderate fall risk: 21-40
    • High fall risk: 0-20

    Measured: 4 Weeks

  2. Timed Up and Go Test (TUG)

    A simple test used to assess mobility, balance, walking ability, and fall risk. The participant is timed while standing up from a chair, walking 3 meters, turning around, walking back, and sitting down.

    Scoring: Time recorded in seconds

    • <10 sec: Normal mobility
    • 10-20 sec: Good mobility, mostly independent
    • >20 sec: Limited mobility, may require assistance

    Measured: 4 Weeks

  3. Postural Assessment Scale for Stroke Patients (PASS)

    A stroke-specific tool used to assess postural control in lying, sitting, and standing positions. It includes 12 items that evaluate the ability to maintain or change postures.

    Scoring: Each item scored 0-3 (Total score: 36) Higher scores indicate better postural control.

    Measured: 4 Weeks

  4. Fugl-Meyer Assessment - Lower Extremity (FMA-LE)

    A quantitative measure to assess motor recovery of the lower extremities in post-stroke patients. Evaluates reflexes, movement, coordination, and joint function.

    Scoring: Each item scored on a 3-point scale (0 = cannot perform, 2 = performs fully)

    • Maximum score: 34 for lower extremity

    Measured: 4 Weeks

  5. Heart Rate Variability (HRV)

    A measure of the variation in time between heartbeats, reflecting autonomic nervous system activity, especially parasympathetic function.

    Scoring: Time-domain and frequency-domain indices (e.g., RMSSD, LF/HF ratio) Higher HRV = better autonomic flexibility.

    Measured: 4 Weeks

  6. Blood Pressure Variability (BPV)

    Evaluates variations in blood pressure over time, indicating autonomic regulation and cardiovascular stability.

    Scoring: Standard deviation (SD), coefficient of variation (CV), or spectral analysis

    • Abnormal variability may reflect autonomic dysfunction

    Measured: 4 Weeks

  7. Skin Conductance and Skin Temperature

    Measures sweat gland activity and peripheral temperature, indicating sympathetic nervous system activity.• Increased skin conductance = higher sympathetic arousal

    • Changes in skin temperature may reflect vasoconstriction/dilation

    Measured: 4 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2026
  2. Study start20 May 2026
  3. Primary completion20 Oct 2026 (estimated)
  4. Study completion20 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
22 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07629687
Sponsor's protocol ID
02268 / Hajra Arshad
Status last verified
Jul 2026
First submitted
1 Jun 2026
Last updated
20 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Vagus Nerve Stimulation combined with Balance Training Group and Balance Training Group in people with Stroke, run by Riphah International University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Arshad Nawaz Malik, PhD Rehab (03334503754, arshad.nawaz@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Berg Balance Scale (BBS) (time frame: 4 Weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in